Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02422615
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2015-04-01
Brief Title:
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive HER2-negative Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MONALEESA-3
Brief Summary:
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive HR HER2-negative advanced breast cancer
Detailed Description:
This study was a randomized phase III double-blind placebo-controlled international trial aimed at determining the efficacy and safety of treatment with fulvestrant in combination with ribociclib compared to fulvestrant with placebo in men and postmenopausal women diagnosed with HR HER2-negative advanced breast cancer The study comprised four phases screening up to 28 days randomized treatment post-treatment disease progression follow-up and post-treatment survival follow-up
Enrolled participants were randomly assigned to receive either fulvestrantribociclib or fulvestrantplacebo in a ratio of 21 The randomization process was stratified based on the presence of liver andor lung metastases yes versus no and prior endocrine therapy Treatment was administered until disease progression occurrence of unacceptable toxicity or discontinuation from the study treatment for other reasons
Participants who discontinued treatment due to reasons other than disease progression or withdrawal of consent for efficacy follow-up continued to be monitored until disease progression death withdrawal of consent loss to follow-up or subjectguardian decision
All participants who discontinued treatment were followed for survival until the predetermined number of overall survival OS events was reached
A protocol amendment 4 dated 29-Jan-2020 allowed for unblinding of study participants and those still receiving placebo had the option to switch to the ribociclib arm The decision for crossover was made at the investigators discretion and required patient consent
Enrolled participants were randomly assigned to receive either fulvestrantribociclib or fulvestrantplacebo in a ratio of 21 The randomization process was stratified based on the presence of liver andor lung metastases yes versus no and prior endocrine therapy Treatment was administered until disease progression occurrence of unacceptable toxicity or discontinuation from the study treatment for other reasons
Participants who discontinued treatment due to reasons other than disease progression or withdrawal of consent for efficacy follow-up continued to be monitored until disease progression death withdrawal of consent loss to follow-up or subjectguardian decision
All participants who discontinued treatment were followed for survival until the predetermined number of overall survival OS events was reached
A protocol amendment 4 dated 29-Jan-2020 allowed for unblinding of study participants and those still receiving placebo had the option to switch to the ribociclib arm The decision for crossover was made at the investigators discretion and required patient consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-000617-43 | EUDRACT_NUMBER | None | None |